Clinical Trials - Cancer Research Institute (CRI)

B-Cell Leukemia or Lymphoma (formely called Acute Lymphoblastic Leukemia)

Study Overview

This is a Phase I/II, open label, dose escalation, multi-dose study of DT2219ARL for treatment of B-Cell Leukemia and Lymphoma. DT2219ARL is an immunotoxin targeting CD19 and CD22 present on certain cancerous B-Cells.

It is anticipated that approximately 20 patients will be enrolled in this study over the next two years. Patients will receive full supportive care including transfusions, antibiotics, fluids, electrolytes, growth factors, antimetrics, etc. when appropriate. However, patients are not allowed intravenous immunoglobulin, other cancer chemotherapy or radiation during the study. Patients will be hospitalized for approximately nine days for the completion of the four doses, every other day dosing schedule.

Patients initially will have follow-up blood work every two to three days and doctor’s visits on days 15 and 28. Patients who achieve remission will be followed monthly with blood work and every three months with bone marrows until relapse or progression.

Patient Eligibility:

• At least 18 years old.
• B-Cell leukemia or lymphoma and evidence of relapse/refractory disease.
• Presence of CD19 and/or CD22 on cancerous cells.
• Recovered from effects of prior therapy and at least two weeks since the last dose of chemo.
• Relapsed following bone marrow transplant.
• Adequate renal function.
• Adequate liver function.
• Adequate cardiac function.
• No serious concurrent medical conditions, CNS disease, uncontrolled infections or heart attack in the last six months, or disseminated intravascular coagulopathy (DIC).
• Agree to practice effective methods of contraception during the course of study.

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